# K012824: Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Nov 9, 2001 after 78 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002337 (2000). 1 ancestor in all.
90 later devices descend from it; 3 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002337: Branan Medical Corporation Monitect Barbiturates Drug Screen Test, Branan Medical Corporation (2000) Summary page 2.

## Most influential descendants
- K023946: Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device (2003), 86 descendants of its own
- K031759: Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card (2003), 83 descendants of its own
- K061718: Innovacon Spectrum II Test Card (2006), 80 descendants of its own
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (2013), 55 descendants of its own
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), 16 descendants of its own

## Indications for use
The ACON BAR One Step Barbiturates Test Strip and ACON BAR One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of barbiturates in human urine at a level relative to the secobarbital cut-off concentration of 300 ng/mL. They are intended for use by healthcare professionals including professionals at point of care sites.

Source page: https://510kreport.com/device/K012824
Methodology: https://510kreport.com/methodology